Running oncology studies globally

We plan & execute seamless clinical trials with novel study designs

PSI’s key differentiator is our ability to plan and execute complex clinical trials on time, saving our customers millions of development dollars.

As a leading oncology CRO, we have diverse experience in various classes of small molecules and biologics across a broad spectrum of cancers, including lung, breast, GI, GU, skin, leukemias, lymphomas, multiple myeloma, and MPNs. Our deep experience goes even further, including:

  • Immunotherapies (including checkpoint inhibitors, cancer vaccines, CAR-T cell therapies, bispecific antibodies and cytokines)
  • Radiopharmaceuticals (in diagnostic and therapeutic setting)
  • Cancer supportive care medications (in cytopenias, nausea/vomiting, mucositis, fungal infections)
  • Biosimilar medicines
  • Early phase studies including basket/umbrella designs

Patient populations

• PSI works with hundreds of sites in six continents in a variety of oncological indications.
• 90% of our Project Managers and 79% of our CRAs have oncology experience.
• PSI aced multiple FDA and EMA inspections resulting in drug approvals in breast, lung, prostate, colorectal, renal, pancreatic cancers, as well as various types of supportive care.

 

Biosimilars in Oncology

Thanks to PSI’s broad access to sites in the developing countries, PSI remains a key player in providing successful patient enrollment and full-service management of biosimilar oncology trials. Our sites all over Eastern Europe, India, South Africa and Latin American countries often play an important role in enabling speedy patient enrollment and high quality of data for trials that turn out to be particularly difficult to execute in more Western countries.

Novel Target Therapies

PSI has an impressive track-record of managing studies of checkpoint inhibitors and other IO agents/target biologics. Increasingly breakthrough therapies are being identified earlier, and some are being approved based on a single combined phase I/II trials. More and more common is to see new target therapies being studied for multiple tumor targets, and in combination with other drugs in multiple regimens.

PSI has cultivated alliances with laboratories known for their expertise in Next Generation Sequencing as well as technology companies that specialize in Artificial Intelligence platforms for analysis of medical and genetic data, which enables recruiting subsets of ultra-rate patients sharing the same actionable target. Add those alliances to our large network of valued, global sites, and you can see an oncology CRO that is truly committed to on-time enrollment.

Valued Sites Network

PSI recognizes that site relationships play an integral role in clinical trial success. We proactively cultivate those relationships by reaching out internationally to identify and recruit an elite group of top performing sites and investigators who share our commitment to optimize access to eligible patients, decrease start-up times and administrative burden and enable multiple efficiencies which support PSI’s goal to consistently deliver high quality clinical trials on time and on budget.

Our Valued Site network includes a cadre of sites including leading academic centers, community cancer centers, private oncology practices and site networks willing to enter into pro-active business agreements and interested in pursuing a mutually beneficial multi-study relationship with PSI.

We work collaboratively with our Valued Sites to develop streamlined processes which decrease start-up timelines and promote efficiencies for our sponsors, sites, and PSI. Not only do these arrangements decrease workload, but Valued Sites also enjoy special privileges which afford investigators opportunities to participate in focus groups or provide early input on protocols or product development which serve their specific research interests. We understand the need to have products reach the market and patients quickly. Utilizing the PSI Valued Site network can help support that goal.

“PSI has been exceedingly professional and is respected by our site as a great collaborator.”

Anthony W. Tolcher, MD, FRCP, FACP

The PSI Advantage

PSI CRO has been named a 2022 CRO Leadership Award Champion in the categories of Compatibility, Quality, and Reliability across two respondent groups (Overall and Small Pharma). This is also the fourth year in a row in which PSI CRO received CRO Leadership Awards in all five categories, also including Expertise and Capabilities. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

Therapeutic areas

Inflammatory Bowel Diseases (IBD)

Crohns’ Disease, Ulcerative Colitis and other IBDs.

Oncology

Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Ovarian Cancer and other Oncology indications.

Hematology

Multiple Myeloma, Lymphomas, Leukemias and other oncohematological indications.

Infectious Diseases

Antimicrobial and Antifungal infections and other ID.

Multiple Sclerosis

Multiple Sclerosis, Spasticity and other neurological indications.

Rare Diseases

Hemophilia A & B, Von Willebrand Disease, Thrombocytopenia, Polycythemia Vera, Paroxysmal Nocturnal Hemoglobinuria (PNH).